Oral drug dosage forms for colon delivery and methods of use and making thereof

A method of designing an oral drug dosage form configured to release a drug at a desired gastrointestinal location in an individual,

• wherein the oral drug dosage form comprises:
• a drug component comprising:
• a first erodible material admixed with a drug, and
• a first erodible tracking stripe;
• and
• a shell comprising a second tracking stripe;
• a delay component not admixed with the drug, the delay component comprising:
• a pH-based enteric member configured to erode at or above a pre-determined pH value,
• wherein the pH based enteric member comprises a third erodible tracking stripe;
• and
• an erodible delay member comprising a second erodible material, wherein the erodible delay member comprises a fourth erodible tracking stripe,
• wherein the pH-based enteric member, alone or in combination with the shell, prevents erosion of the erodible delay member, and
• wherein the erodible delay member, alone or in combination with the shell, prevents erosion of the drug component,
• the method comprising:
• (a) administering the oral drug dosage form to an individual;
• (b) imaging the individual over a time course to obtain a location of the oral drug dosage form and a status of the first erodible tracking stripe, the second erodible tracking stripe, the third erodible tracking stripe, and the fourth tracking stripe;
• and
• (c) adjusting the drug component and/or delay component and/or shell, or portion thereof, based on the location and the status of the first erodible tracking stripe, the second erodible tracking stripe, the third erodible tracking stripe, and the fourth track stripe to design the oral drug dosage form configured to release a drug at a desired gastrointestinal location in an individual.

A method of designing an oral drug dosage form configured to release a drug at a desired gastrointestinal location in an individual,

• wherein the oral drug dosage form comprises:
• a drug component comprising:
• a first erodible material admixed with a drug, and
• a first erodible tracking stripe;
• and
• a shell;
• a delay component not admixed with the drug, the delay component comprising:
• a pH-based enteric member configured to erode at or above a pre-determined pH value;
• and
• an erodible delay member comprising a second erodible material,
• wherein the pH-based enteric member, alone or in combination with the shell, prevents erosion of the erodible delay member, and
• wherein the erodible delay member, alone or in combination with the shell, prevents erosion of the drug component,
• the method comprising:
• (a) administering the oral drug dosage form to an individual;
• (b) imaging the individual over a time course to obtain a location of the oral drug dosage form and a status of the first erodible tracking stripe;
• and
• (c) adjusting the drug component and/or delay component and/or shell, or portion thereof, based on the location and the status of the first erodible tracking stripe, to design the oral drug dosage form configured to release a drug at a desired gastrointestinal location in an individual.

A method of designing an oral drug dosage form configured to release a drug at a desired gastrointestinal location in an individual,

• wherein the oral drug dosage form comprises:
• a drug component comprising a first erodible material admixed with a drug;
• a shell;
• and
• a delay component not admixed with the drug, the delay component comprising:
• a pH-based enteric member configured to erode at or above a pre-determined pH value;
• and
• an erodible delay member comprising a second erodible material,
• wherein the pH-based enteric member prevents erosion of the erodible delay member, and
• wherein the erodible delay member prevents erosion of the drug component,
• wherein the oral drug dosage form comprises at least one tracking stripe positioned in a component thereof,
• the method comprising:
• (a) administering the oral drug dosage form to an individual;
• (b) imaging the individual over a time course to obtain a location of the oral drug dosage form and a status of the at least one tracking stripe;
• and
• (c) adjusting the drug component and/or delay component and/or shell, or portion thereof, based on the location and the status of the at least one tracking stripe, to design the oral drug dosage form configured to release a drug at a desired gastrointestinal location in an individual.

A method of designing an oral drug dosage form configured to release a drug at a desired gastrointestinal location in an individual,

• wherein the oral drug dosage form comprises:
• a drug component comprising a first erodible material admixed with a drug;
• and
• a delay component not admixed with the drug, the delay component comprising:
• a pH-based enteric member configured to erode at or above a pre-determined pH value;
• and
• an erodible delay member comprising a second erodible material,
• wherein the pH-based enteric member prevents erosion of the erodible delay member, and
• wherein the erodible delay member prevents erosion of the drug component,
• wherein the oral drug dosage form comprises at least one tracking stripe positioned in a component thereof,
• the method comprising:
• (a) administering the oral drug dosage form to an individual;
• (b) imaging the individual over a time course to obtain a location of the oral drug dosage form and a status of the at least one tracking stripe;
• and
• (c) adjusting the drug component and/or delay component, or portion thereof, based on the location and the status of the at least one tracking stripe, to design the oral drug dosage form configured to release a drug at a desired gastrointestinal location in an individual.